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The proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed Tomography applications in oncology as part of treatment preparation and radiation therapy planning, vascular, interventional, neurology and cardiology, for patients of all ages.

These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or a professional medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The proposed CT Rembra RT, CT Areta RT, and CT Rembra proposed devices have similar technological characteristics, software operating platform, and supported software characteristics as the predicate devices.

The proposed devices expand the CT product family with improved performance, workflow and functionality for oncology applications. They also provide a large-bore radiology solution on the Incisive Host software platform.

The design of the proposed CT Rembra RT, CT Areta RT, CT Rembra is based on the currently marketed CT 5300 (K232491), with hardware and software modifications. These include the addition of new oncology software features and workflow enhancements for radiotherapy planning support.

The proposed system is a whole-body computed tomography (CT) x-ray system featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. It produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Philips. The CT images can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system.

The proposed device has an 85 cm bore and includes a detector array that provides 60 cm scan field of view (SFOV) and 85cm extended field of view (EFOV).

The key system modules and functionalities of proposed device are: Gantry [X-ray tube assembly, HV generator, Collimator, DMS (Data Measurement System), Touch Panels], Patient Table (Couch), Console and optional components as well as accessories. This system also includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images.

Upgrade Kits are available to upgrade CT Rembra RT, CT Areta RT, CT Rembra installations to the latest version in forward production.

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